Faecal Immunochemical Test (FIT) for Bowel Cancer Detection - Now recommended by NICE DG30
High quality measurement of faecal haemoglobin for both asymptomatic and symptomatic assessment for bowel cancer and other colorectal diseases
FIT provides better analytical sensitivity and specificity for human haemoglobin and is superior in detection of adenomatous polyps as well as colorectal cancers (CRC).
The new NICE Guidance DG30 now recommends the use of quantitative faecal immunochemical tests to assess symptomatic patients in primary care who are at low risk of colorectal cancer.
Alpha Laboratories has many years experience in faecal haemoglobin testing having been involved with the UK Bowel Cancer Screening Programmes since 1998. Our solution for FIT stool testing is the HM-JACKarc system that offers fully automated testing and simple, hygienic sample collection for patients.
The HM-JACKarc is a high throughput, fully automated system that provides quantitative faecal haemoglobin concentration results on a simple to use platform.
It has a wide dynamic range from 7ng/ml to 400 ng/ml (ng/ml = µg Hb/g faeces), making it ideal for use in clinical settings for both asymptomatic screening and assessment of the symptomatic.
In recent years, some countries have replaced the traditional guaiac based faecal occult blood tests (gFOBT) strategy for screening with Faecal Immunochemical Tests for haemoglobin (FIT), since they provide better analytical sensitivity and specificity for human haemoglobin and are superior in detection of adenomatous polyps as well as colorectal cancers (CRC).
The use of FIT in the assessment of the symptomatic is changing too, as more publications have demonstrated that the use of quantitative FIT as a “rule-out” test has benefits to clinicians, laboratories and patients.
A recently accepted article, concluded that FIT is highly accurate for the detection of CRC in symptomatic patients and was more so than the NICE (National Institute for Health and Care Excellence) and SIGN (Scottish Intercollegiate Guidelines Network) referral criteria. This work demonstrated that, when FIT with a 20 µg Hb/g faeces cut-off concentration was used instead of the NICE referral criteria, 19.6% fewer colonoscopies would have been needed to detect 42% additional CRC.
Quantitative FIT (qFIT) results have demonstrated greater sensitivity for cancers and high risk adenomas than guaiac and it is accepted that increasing detection levels of faecal haemoglobin (f-Hb) are indicative of increased risk of pathology 1,2.
Currently, there are many studies, published and in progress, that examine the usefulness of measuring faecal haemoglobin quantitatively in those presenting with symptoms. In this setting, FIT could reduce the burden of colonoscopy in a similar way that calprotectin testing has, when FIT is adopted as a routine test for the symptomatic.
NICE Guidance DG30 “Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care” was published in July 2017, following evidence based reviews. This recommends quantitative faecal immunochemical tests for adoption in primary care to guide referral for suspected colorectal cancer in people without rectal bleeding who have unexplained symptoms but do not meet the criteria for a suspected cancer pathway referral outlined in NICE's guideline on suspected cancer.
NICE confirms that results should be reported using a threshold of 10 micrograms of haemoglobin per gram of faeces.
The new NICE guidance states that
...[FIT] assays were also cost effective when compared with no triage, with the HM-JACKarc dominating (that is, it was more effective and less expensive)"
Laboratories who embrace the newer technology of FIT can provide a more proactive service to their community whilst embracing the productivity benefits of an automated system.
Introducing Faecal Immunochemical Testing for Symptomatic Patients at Monklands Hospital, NHS Lanarkshire
Introducing the FIT Service at Ninewells Hospital & Medical School, NHS Tayside
NICE DG30- The Benefits of Faecal Immunochemical Testing
5.2 The committee discussed the potential benefits that may be associated with
using faecal immunochemical tests in primary care. It heard from clinical
specialists that faecal immunochemical tests are thought to be more accurate
than guaiac-based faecal occult blood tests because they use immunochemical
detection methods that are specific to human haemoglobin. They are also
suitable for use with automated analysers, which allow high-throughput batch
testing. It also heard from a patient specialist that faecal immunochemical tests
often had sample collection devices that are easier to use than guaiac-based
faecal occult blood tests and they need fewer samples, which makes them more
acceptable to people and so may increase test uptake. The committee concluded
that faecal immunochemical tests may have substantial analytical and practical
advantages over guaiac-based faecal occult blood tests.
The Benefits of Using HM-JACKarc for Automated FIT
The HM-JACKarc system is easy to set up and can be loaded with up to 80 samples at any one time. It can stand alone or be linked to the LIS, allowing flexible options for connectivity and full audit trail of results, QC and reagent lot numbers.
Advanced Sample Collection System
Easy to use sample device collects a consistent sample size across different faecal matter
Internal septum removes excess sample
<2mg of sample in 2ml of buffer (ng/ml = µg Hb / g faeces)
Tamper seal and window to confirm sample applied
Unique bar code number for the tube (lot no./expiry date/tube no.
Collection buffer stabilises the faecal sample haemoglobin
• 120 days at 04°C (refrigerated)
• 14 days at 25°C (ambient temp)
Fully Automated Instrument
Compact and light bench top unit with touchscreen interface
Uses Integrated Sphere Latex Turbidimetry to measure faecal haemoglobin concentration
Sensitivity: 7 ng/mL
Cut-off concentrations can be selected depending on requirements – Screening or Symptomatic Testing
No prozone effect up to 200,000 ng/mL
High speed performance: 200 samples/hour
• Time to first result 5.6 minutes
• Additional results every 18 seconds
Factory set Master curve with local 2 point recalibration
• Calibrates system to local conditions and reagent combinations
• Calibration weekly
System can store 2 calibration curves
• Calibration of different lots of latex
• Same lots with different calibrators
Provides a large concentration of capture antibodies
Wide dynamic range 7ng/ml to 400 ng/ml (ng/ml = µg Hb/g faeces)
High Hook capacity > 200,000ng/ml Ensures no samples will give a falsely lower result
Drives reaction kinetics to end stage equilibrium quickly
3. A poster was presented by Ian Godber, Consultant Clinical Scientist, Clinical Lead, NHS Lanarkshire, at a workshop during the EuroLabFocus meeting in Liverpool on 8th October 2014.
This study was conducted at Monklands Hospital, where all patients undergoing a colonoscopy were asked to participate by providing a single small faecal sample, easily collected in a hygienic specimen collection device, for analysis on the HM-JACKarc system, before they underwent colonoscopy.
Download the Poster entitled; "Can an automated Faecal Immunochemical Test (FIT) determine whether faecal haemoglobin (f-Hb) concentrations can aid in stratifying symptomatic patients referred for colonoscopy".
Evaluates the HM-JACKarc for technical performance for specificity, sensitivity and precision across a range of different haemoglobin concentrations when stored in specific temperatures. Confirms the suitability of the system for the detection of haemoglobin in faecal samples
HM 2. Clinical Utility of HM-JACKarc for the Detection of Colorectal Cancer and High Risk Adenomas, JM AUGE Fradera et al., Laboratory of Biochemistry, School of Medicine, Hospital Clinic, Barcelona. Mar2014
HM4. Studies on HM JACK for Fecal Occult Blood Analyser, Yutaka Nara, Noriko Harashima, Hitoshi Ikeda, Dept.of Laboratory Medicine, Saitama Medical Centre. The Saitima Journal of Medical technology 1999 vol. 46
The HM-JACK was shown to yield favourable intra and inter –day precision and accuracy,sufficient measurement range and stability of Hb after sampling.This analyser is fast and easy to use analysing 180 sample/hour.In addition ,stool sampling using piercing procedure yields good reproducibility making it a good choice for routine use.
HM5. Comparison of fecal occult blood assay by four companies. Sayuri Nakayasu et al, Division of Laboratory, Matsuai-kai, Matsuda Hospital
Compares the clinical sensitivity and specificity of reagents for Kyowa Medex ,Wako.Fujirebio and Azwell Co. Specificity comparison revealed that the kits of manufacturers using a high fecal concentration in the fecal sampler after sampling (i.e., final fecal concentration) tended to have a lower specificity. The important factors that impact on the sensitivity and specificity of the various kits are the determination of the cut-off value, the accuracy of fecal sampling and the characteristics of the antibody that is used.
HM 6. Evaluation of the Extel “Hemo Auto” HS and the Hemo Auto MC Feces Collection Container Using the HM-JACKarc Fully Automated Fecal Occult Human Hemoglobin Analyzer. Masahiro ITOH*1, Tsuyoshi FUKUDA*2, Go NAGAI*3 , Journal of Clinical Laboratory Instruments and Reagents, Vol. 34, No. 3 (June, 2011) – Supplement
An in house evaluation of HM-JACKarc covering specificity, sensitivity, prozone, sample stability etc.
Undetectable FIT is a good strategy to rule out ACRN. The diagnostic yield of 2 samples can be achieved with 1 sample but a lower cut off must be used.
Alpha Laboratories has been at the forefront of faecal testing in the UK for nearly 20 years. This was initially as the market leader for guaiac-based faecal occult blood testing in hospital laboratories. Tender wins for bowel screening in all four UK countries followed this, as each launched its own screening programme, assessing the average risk asymptomatic populations.
Continuing to provide leading edge products, Alpha Laboratories has been awarded the first contract for quantitative FIT as the front line test in the Scottish Bowel Screening Programme. This will employ the Kyowa Medex HM-JACKarc system. England will also be moving to a quantitative FIT method in the NHS Bowel Cancer Screening Programme in the near future, for which Alpha Laboratories was also successful in the tender for a framework agreement.